search
Back to results

The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain

Primary Purpose

Obesity, Morbid

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
IV paracetamol
IV saline (NaCl 0.9 %)
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring morbidly obese, ,elective sleeve, gastrectomy, paracetamol, IV Perfelgan

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥18 years
  • Patients admitted for laparoscopic sleeve gastrectomy
  • Elective surgery
  • BMI > 40
  • American Society of Anesthesiology Classification: 1-2

Exclusion Criteria:

  • Patients' refusal to participate in the study
  • Patients unable to give an informed consent
  • Pregnancy
  • Emergency surgery
  • Patient with known allergy to paracetamol
  • Patient with hepatic failure
  • international normalized ratio >1.7
  • Albumin<3.5g/Dl
  • Bilirubin >2mg/dL
  • Patient with fever > 37.5 ° C
  • Patient with hemoglobin < 8
  • Patients chronically treated with steroids or steroid-treated patients over a month in the year preceding surgery.

Drug addict

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    IV paracetamol

    IV saline (NaCl 0.9 %)

    Arm Description

    Patients in the first group will receive in the operating room before surgery 1 gram (100 ml) of intravenous paracetamol ( IV paracetamol) for 15 minutes intraoperative

    Patients in the second group will receive 100 mL NACL 0.9% (IV NaCl 0.9 %)intraoperative

    Outcomes

    Primary Outcome Measures

    measuring of Visual Analogue pain Scale,
    Visual Analogue pain Scale to determine patient level of pain , for establish the correct timing of paracetamol administration
    measuring of Cytokine levels
    measuring of Cytokine levels in comparison of timing of paracetamol administration , as a predictor for inflammatory mediators released in response to noxious stimuli

    Secondary Outcome Measures

    Total consumption of opiates after surgery
    post - operative opioid consumption in manner of dosage and frequency in ward
    Respiratory post-operative complication while in ward
    Respiratory complication (need of respiratory support, need of intensive care unit hospitalization)
    septic post-operative complication while in ward
    development of fever above 38° C
    Cardiovascular post-operative complication while in ward
    Cardiovascular complication (hemodynamic instability, inotropic support )
    Gastrointestinal post-operative complication while in ward
    Gastrointestinal complaints as nausea and vomiting, need to use antiemetic drug
    urinary trak post-operative complication while in ward
    Incidence of urinary retention and need for catheterization
    post-operative pruritus while in ward
    Pruritus
    post-operative hospitalization
    length of hospital stay by number of days
    Respiratory post-operative complication while recovering in post anesthesia care unit
    Respiratory complication need of respiratory support, need of intensive care unit hospitalization)
    septic post-operative complication while recovering in post anesthesia care unit
    Development of fever above 38° C
    Cardiovascular post-operative complication while recovering in post anesthesia care unit
    Cardiovascular complication (hemodynamic instability, inotropic support )
    Gastrointestinal post-operative complication while recovering in post anesthesia care unit
    Gastrointestinal complication as nausea and vomiting, need to use antiemetic drugs
    urinary retention post-operative complication while recovering in post anesthesia care unit
    incience of urinary retention and need for catheterization
    post-operative pruritus while recovering in post anesthesia care unit
    Pruritus
    post-operative stay in post anesthesia care unit
    length of post anesthesia care unit stay by number of hours

    Full Information

    First Posted
    June 30, 2017
    Last Updated
    July 23, 2017
    Sponsor
    Soroka University Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03221998
    Brief Title
    The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain
    Official Title
    The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain and Cytokines Levels Following Laparoscopic Sleeve Gastrectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2017 (Anticipated)
    Primary Completion Date
    March 2019 (Anticipated)
    Study Completion Date
    March 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Soroka University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity
    Detailed Description
    All adult consecutive patients admitted to surgical departments for laparoscopic sleeve gastrectomy will be enrolled prospectively. For the purposes of the current study we want to determine how much paracetamol (acetaminophen) can reduce the cytokines levels in these patients The study enrollment period is planned to be a year. The follow-up period for each patient will be until discharge from the hospital.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Morbid
    Keywords
    morbidly obese, ,elective sleeve, gastrectomy, paracetamol, IV Perfelgan

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    126 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IV paracetamol
    Arm Type
    Experimental
    Arm Description
    Patients in the first group will receive in the operating room before surgery 1 gram (100 ml) of intravenous paracetamol ( IV paracetamol) for 15 minutes intraoperative
    Arm Title
    IV saline (NaCl 0.9 %)
    Arm Type
    Placebo Comparator
    Arm Description
    Patients in the second group will receive 100 mL NACL 0.9% (IV NaCl 0.9 %)intraoperative
    Intervention Type
    Drug
    Intervention Name(s)
    IV paracetamol
    Other Intervention Name(s)
    Perfalgan infusion (paracetamol)
    Intervention Description
    100 gram paracetamol infusion for moderate pain management
    Intervention Type
    Drug
    Intervention Name(s)
    IV saline (NaCl 0.9 %)
    Other Intervention Name(s)
    Normal Saline
    Intervention Description
    100 ml of Normal Saline (IV NaCl 0.9 %) as placebo
    Primary Outcome Measure Information:
    Title
    measuring of Visual Analogue pain Scale,
    Description
    Visual Analogue pain Scale to determine patient level of pain , for establish the correct timing of paracetamol administration
    Time Frame
    up to 48 hours after surgery
    Title
    measuring of Cytokine levels
    Description
    measuring of Cytokine levels in comparison of timing of paracetamol administration , as a predictor for inflammatory mediators released in response to noxious stimuli
    Time Frame
    up to 48 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Total consumption of opiates after surgery
    Description
    post - operative opioid consumption in manner of dosage and frequency in ward
    Time Frame
    up to 72 hours after surgery
    Title
    Respiratory post-operative complication while in ward
    Description
    Respiratory complication (need of respiratory support, need of intensive care unit hospitalization)
    Time Frame
    up to 72 hours after surgery
    Title
    septic post-operative complication while in ward
    Description
    development of fever above 38° C
    Time Frame
    up to 72 hours after surgery
    Title
    Cardiovascular post-operative complication while in ward
    Description
    Cardiovascular complication (hemodynamic instability, inotropic support )
    Time Frame
    up to 72 hours after surgery
    Title
    Gastrointestinal post-operative complication while in ward
    Description
    Gastrointestinal complaints as nausea and vomiting, need to use antiemetic drug
    Time Frame
    up to 72 hours after surgery
    Title
    urinary trak post-operative complication while in ward
    Description
    Incidence of urinary retention and need for catheterization
    Time Frame
    up to 72 hours after surgery
    Title
    post-operative pruritus while in ward
    Description
    Pruritus
    Time Frame
    up to 72 hours after surgery
    Title
    post-operative hospitalization
    Description
    length of hospital stay by number of days
    Time Frame
    up to one week after surgery
    Title
    Respiratory post-operative complication while recovering in post anesthesia care unit
    Description
    Respiratory complication need of respiratory support, need of intensive care unit hospitalization)
    Time Frame
    up to 5 hours after surgery
    Title
    septic post-operative complication while recovering in post anesthesia care unit
    Description
    Development of fever above 38° C
    Time Frame
    up to 5 hours after surgery
    Title
    Cardiovascular post-operative complication while recovering in post anesthesia care unit
    Description
    Cardiovascular complication (hemodynamic instability, inotropic support )
    Time Frame
    up to 5 hours after surgery
    Title
    Gastrointestinal post-operative complication while recovering in post anesthesia care unit
    Description
    Gastrointestinal complication as nausea and vomiting, need to use antiemetic drugs
    Time Frame
    up to 5 hours after surgery
    Title
    urinary retention post-operative complication while recovering in post anesthesia care unit
    Description
    incience of urinary retention and need for catheterization
    Time Frame
    up to 5 hours after surgery
    Title
    post-operative pruritus while recovering in post anesthesia care unit
    Description
    Pruritus
    Time Frame
    up to 5 hours after surgery
    Title
    post-operative stay in post anesthesia care unit
    Description
    length of post anesthesia care unit stay by number of hours
    Time Frame
    up to 5 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age ≥18 years Patients admitted for laparoscopic sleeve gastrectomy Elective surgery BMI > 40 American Society of Anesthesiology Classification: 1-2 Exclusion Criteria: Patients' refusal to participate in the study Patients unable to give an informed consent Pregnancy Emergency surgery Patient with known allergy to paracetamol Patient with hepatic failure international normalized ratio >1.7 Albumin<3.5g/Dl Bilirubin >2mg/dL Patient with fever > 37.5 ° C Patient with hemoglobin < 8 Patients chronically treated with steroids or steroid-treated patients over a month in the year preceding surgery. Drug addict
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yair Binyamin, MD
    Phone
    +972586963871
    Email
    Yairben1@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yair Yaish Reina, MD
    Phone
    +972545442655
    Email
    yair0026@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Semionov, MD
    Organizational Affiliation
    Soroka University Medical Center-Department of Anesthesiology
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Alexander Zlotnic, PhdMD
    Organizational Affiliation
    Soroka University Medical Center-Department of Anesthesiology
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Yair Binyamin, MD
    Organizational Affiliation
    Soroka University Medical Center-Department of Anesthesiology
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yair Yaish Reina, MD
    Organizational Affiliation
    Soroka University Medical Center-Department of Anesthesiology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27177956
    Citation
    Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13.
    Results Reference
    background
    PubMed Identifier
    23054575
    Citation
    Salihoglu T, Salihoglu Z, Zengin AK, Taskin M, Colakoglu N, Babazade R. The impacts of super obesity versus morbid obesity on respiratory mechanics and simple hemodynamic parameters during bariatric surgery. Obes Surg. 2013 Mar;23(3):379-83. doi: 10.1007/s11695-012-0783-0.
    Results Reference
    result
    PubMed Identifier
    23011043
    Citation
    Rieg AD, Stoppe C, Rossaint R, Coburn M, Hein M, Schalte G. [EzPAP(R) therapy of postoperative hypoxemia in the recovery room : experiences with the new compact system of end-expiratory positive airway pressure]. Anaesthesist. 2012 Oct;61(10):867-74. doi: 10.1007/s00101-012-2083-4. Epub 2012 Sep 27. German.
    Results Reference
    result
    PubMed Identifier
    22833138
    Citation
    Cullen A, Ferguson A. Perioperative management of the severely obese patient: a selective pathophysiological review. Can J Anaesth. 2012 Oct;59(10):974-96. doi: 10.1007/s12630-012-9760-2. Epub 2012 Jul 26.
    Results Reference
    result
    PubMed Identifier
    22250276
    Citation
    Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458.
    Results Reference
    result
    PubMed Identifier
    21823370
    Citation
    Macintyre PE, Loadsman JA, Scott DA. Opioids, ventilation and acute pain management. Anaesth Intensive Care. 2011 Jul;39(4):545-58. doi: 10.1177/0310057X1103900405.
    Results Reference
    result
    PubMed Identifier
    21516915
    Citation
    Schug SA, Raymann A. Postoperative pain management of the obese patient. Best Pract Res Clin Anaesthesiol. 2011 Mar;25(1):73-81. doi: 10.1016/j.bpa.2010.12.001.
    Results Reference
    result
    PubMed Identifier
    21252836
    Citation
    Daszkiewicz A, Wylezol M. Postoperative analgesia in a morbidly obese patient with chronic renal failure. Anestezjol Intens Ter. 2010 Oct-Dec;42(4):197-200.
    Results Reference
    result
    PubMed Identifier
    21224800
    Citation
    Ahmed S, Morrow E, Morton J. Perioperative considerations when operating on the very obese: tricks of the trade. Minerva Chir. 2010 Dec;65(6):667-75.
    Results Reference
    result
    PubMed Identifier
    20608558
    Citation
    Pelosi P, Gregoretti C. Perioperative management of obese patients. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):211-25. doi: 10.1016/j.bpa.2010.02.001.
    Results Reference
    result
    PubMed Identifier
    19961114
    Citation
    Hans GA, Lauwick S, Kaba A, Brichant JF, Joris JL. Postoperative respiratory problems in morbidly obese patients. Acta Anaesthesiol Belg. 2009;60(3):169-75.
    Results Reference
    result
    PubMed Identifier
    11748392
    Citation
    Bodian CA, Freedman G, Hossain S, Eisenkraft JB, Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001 Dec;95(6):1356-61. doi: 10.1097/00000542-200112000-00013.
    Results Reference
    result
    PubMed Identifier
    21495003
    Citation
    Heinrich S, Horbach T, Salleck D, Birkholz T, Irouschek A, Schmidt J. [Perioperative anaesthesiological management in 167 patients undergoing bariatric surgery]. Zentralbl Chir. 2011 Dec;136(6):604-11. doi: 10.1055/s-0031-1271382. Epub 2011 Apr 14. German.
    Results Reference
    result

    Learn more about this trial

    The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain

    We'll reach out to this number within 24 hrs